Friday, March 21, 2014 11:09:44 AM
Just to clarify what the fear might be over the DMC delay. I don't think it's that the trial will be halted for futility. And I don't think it's that investors think that the trial has a major design flaw. IMO it's more that there might have been some irregularity at one or more sites.
I'll give an example. Cytosorbents was doing their blood filter trial in Europe a few years ago. They had a site that didn't follow the randomization protocol. All those patients' stats couldn't be used.
Luckily for Cytosorbents the remaining patients provided statistically significant results and it didn't affect the trial's outcome. But it could have.
Wall Street hates uncertainty. I believe that the lingering fear investors have over the DMC delay is that there's an incident that needs to be investigated. And that it could lead to the need to recruit additional patients, delaying the end of the trial. We need to get this behind us - the sooner we get the DMC decision, the better. I'm still hoping for the Flipper outcome!
I'll give an example. Cytosorbents was doing their blood filter trial in Europe a few years ago. They had a site that didn't follow the randomization protocol. All those patients' stats couldn't be used.
Luckily for Cytosorbents the remaining patients provided statistically significant results and it didn't affect the trial's outcome. But it could have.
Wall Street hates uncertainty. I believe that the lingering fear investors have over the DMC delay is that there's an incident that needs to be investigated. And that it could lead to the need to recruit additional patients, delaying the end of the trial. We need to get this behind us - the sooner we get the DMC decision, the better. I'm still hoping for the Flipper outcome!
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